FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-476-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-826-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-027-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 25, 2022Historical recordClass I
Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2
by Gilead Sciences, Inc.
- Reason
- Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 16, 2024Historical recordClass II
Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
by Teligent Pharma, Inc.
- Reason
- Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64
by Teligent Pharma, Inc.
- Reason
- Superpotent Drug: Minimally superpotent
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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